(9 days)
No
The description focuses on standard ultrasound technology and does not mention any AI/ML components or capabilities.
No.
The device is described as an "ultrasonic pulsed echo imaging and measurement" system for creating "tomographic images", indicating its purpose is diagnostic imaging, not therapeutic intervention.
Yes
Explanation: The device is described as performing "imaging and measurement" and allows "tomographic images to be observable on a video monitor." This information is used by a trained professional for interpretation and diagnosis. The "Indications for Use" section lists various anatomical areas (fetal, abdominal, pediatric, small organ, cardiac) that would be imaged for diagnostic purposes.
No
The device description explicitly mentions hardware components such as a built-in digital scan converter (DSC), main CPU module, video monitor, and photographic unit, indicating it is a hardware-based medical device with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as an ultrasonic imaging and measurement system for various anatomical sites (fetal, abdominal, pediatric, small organ, cardiac). This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body.
- Device Description: The description confirms it's an ultrasonotomograph that produces images on a video monitor. This aligns with an imaging device, not an IVD.
- No mention of in vitro testing: There is no indication that this device is used to perform tests on biological samples.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to create images of internal structures using ultrasound.
N/A
Intended Use / Indications for Use
Ultrasonic pulsed echo imaging and measurement for fetal imaging and other abdominal as well as pediatric, small organ, cardiac.
Product codes
IYO, ITX
Device Description
Model SSI-600/SSI-800 are linear and convex electronic ultrasonotomograph with a built-in digital scan converter (DSC) and main CPU module. The unit allows heart, abdominal organic and fetal tomographic images to be observable on a video monitor. The main unit of SSI-600 is portable and separable from other equipment to be carried for its use at another place as well as being usable in combination with a 10-inch video monitor and a special photographic unit. The main unit of SSI-800 is able to combine with a 12-inch video monitor and a special photographic unit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal, Abdominal, Pediatric, Small Organ (thyroid, parotid, submaxillary gland, testes, and breast), Cardiac, Peripheral Vascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
204455
'JUN 1 0 2004
Premarket Notification [510(k)] Summary
| Trade Name: | SSI-600 / SSI-800 with C343 and L751 Transducers |
|---|---|
| Common Name: | Diagnostic Ultrasound System |
| Classification Name: | Ultrasonic Pulsed Echo Imaging System, 90 IYO |
| (per 21 CFR section 892.1560) | |
| Manufacturer's Name: | SonoScape Company Limited |
| Address: | 4/F., Yizhe Building, Yuquan Road, |
| Nanshan, 518051, Shenzhen, China | |
| Corresponding Official: | Mr. Jinzhong Yao |
| Title: | President |
| Telephone: | (86) 755-26722890 |
| Fax: | (86) 755-26722850 |
Medison SonoAce 600 K000030 Predicate:
Model SSI-600/SSI-800 are linear and convex electronic Device Description: scanning ultrasonotomograph with a built-in digital scan converter (DSC) and main CPU module. The unit allows heart, abdominal organic and fetal tomographic images to be observable on a video monitor. The main unit of SSI-600 is portable and separable from other equipment to be carried for its use at another place as well as being usable in combination with a 10-inch video monitor and a special photographic unit. The main unit of SSI-800 is able to combine with a 12-inch video monitor and a special photographic unit.
Intended Use: Ultrasonic pulsed echo imaging and measurement for fetal imaging and other abdominal as well as pediatric, small organ, cardiac.
Technological Characteristics:
(1) Scanning method: Electronic convex sector scanning, linear scanning
- (2) Display mode: B, B/B, B/M, M
- (3) Grey scale: 256
1
- (4) Frequency of probes: 2.5MHz to 10MHz
- (4) Frequency of probot: E.S.R.H.S. X1.2, X1.5, X2.0, Shift 2mm step
(5) Image Display multiple: X0.8, X1.0, X1.2, X1.5, X2.0, Shift 2mm step - (5) Image Display malliplo: Xero, 1111)
(6) Focusing method: Variable aperture 1-4 focal zone electronic focusing - (7) Display range (max)
Depth 200mm angel 80° (Convex)
Depth 90mm width 50mm (Linear)
(8) Image adjustment
0 to 99 (digital) Gain: 0 to -60 (digital) Near Gain: 0 to 60 (digital) Far Gain: Grey map curve: 4 types Frame Correlation: 4 steps Edge Enhance: 4 steps
(9) Sweep Speed in M Mode: 1, 2, 4, 8sec/frame
- Image Display: left/right, positive/negative (10)
- Cineloop: up to 64 frames, continual/single (11)
- DSC memory capacity: 512 X 512 X 8 bit (12)
- Monitor: 10-inch B/W monitor (13)
- Character display (14)
- (a) Patient's ID
- (b) Hospital Name
- (c) Comment
- (d) Automatically Display Items: Date & time, probe frequency, gain and other operating parameters, and various measured values.
- Body marks: 25 types (15)
- Measuring functions: (16)
- (a) Basic measurement: distance, circumference, area, volume, angle, HR
- (b) Obstetrics measurement: BPD, CRL, FL, AC, HC, GS, VOL, ANG
- (c) Other measurements: MV,LV,TIME,SLOPE,AO
- I/O port (17)
- (a) RS-232C port for transmitting image to PC
- (b) One active convex or linear array ports
- Video system: 625lines/frame, 50fields/second (PAL) (18) or 525lines/frame, 60fields/second (NTSC)
- Dimension 310(W) x 383(L) x 263(H) mm (19)
- Net Weight: about 12kg (20)
- Power Consumption: ~~220V±10%, 100VA (21)
Or ~110V±10%, 100VA
- Environmental Requirements: (22)
- (a) Operating Temperature & Humidity: 5°C to 40°C, 30% to 85%RH
- (b) Atmospheric Pressure: 70 to 160 KPa (700 to 1600 mbars)
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is black and white.
Public Health Service
JUN 1 0 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SonoScape Company Limited % Mr. Bob Leiker Quality and Regulatory Services, Inc. 7263 Cronin Circle DUBLIN CA 94568
Re: K041455
Trade Name: SSI-600 / SSI-800 Diagnostic Ultrasound Systems Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYO and ITX Dated: May 24, 2004 Received: June 1, 2004
Dear Mr. Leiker:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your beenon o succernined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate confinered provices that have been reclassified in accordance with the provisions of the Amendinents, of to devices market Act (Act). You may, therefore, market the device, subject to I edital I ood, Drag, and Oosment Free Act. The general controls provisions of the Act include the general controls provisions of on, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for 1 Ins uctimmation of backandar iagnostic Ultrasound Systems, as described in your premarket notification:
Transducer Model Number
C343 Convex Array L751 Linear Array
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device
3
can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oouoverements concerning your device in the Federal Register. may publish finitier announce of a substantial equivalence determination does not mean r least be advised that I Driving that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I cacharter und regulanents . including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT at 607); adoling (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket This letter will anow you to organization equivalence of your device to a legally marketed nontication. In a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please 11 you debre of Compliance at (301) 594-4591. Additionally, for questions on the comact the Office of compilance at (vice, please contact the Office of Compliance at (301) 594promotion and acreralisms or your tion entitled, "Misbranding by reference to premarket 4057. Also, produse note the regarial information on your responsibilities under the nothreation (21 St. 21 to an the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David A. Segerson
Nancy C. Broadgon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
4
3.1 SonoScape SSI-600/SSI-800 Ultrasound Imaging System
Scanhead Indications for Use Form Device Name: Convex Array C343
| Clinical Application | Mode of Operation | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | |||||
| Doppler | Amplitude | |||||||||
| Doppler | Color | |||||||||
| Velocity | ||||||||||
| Imaging | Combined | |||||||||
| (specify) | Other | |||||||||
| (specify) | ||||||||||
| Ophthalmic | ||||||||||
| Fetal | N | N | N | |||||||
| Abdominal | N | N | N | |||||||
| Intraoperative (specify) | ||||||||||
| Intraoperative | ||||||||||
| Neurological | ||||||||||
| Pediatric | N | N | N | |||||||
| Small Organ (specify) | ||||||||||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac | N | N | N | |||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Transurethrat | ||||||||||
| Intravascular | ||||||||||
| Perpheral Vascular | ||||||||||
| Laparoscopic | ||||||||||
| Musculo-skeletal | ||||||||||
| Conventional | ||||||||||
| Musculo-skeletal | ||||||||||
| superficial | ||||||||||
| Other (specify) |
N=new indication
N Hew indivation
Additional Comments: Pediatric Comments: Pediatric Intended uses include: Cardiology, Abdomen
Indicatio
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IE NEEDED.
Concurrence of CDRH, office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
David A. Heymann
5
SonoScapeCompany,LTD.
1
SonoScapeCompany,LTD.
3.2 SONOSCAPE SSI-600/SSI-800 Ultrasound Imaging System
Scanhead Indications for Use Form
Device Name: Linear Array L751
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | |||||||||||
| Abdominal | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | N | ||||||||||
| Small Organ (specify) | N | ||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethrat | |||||||||||
| Intravascular | |||||||||||
| Peripheral Vascular | N | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| superficial | |||||||||||
| Other (specify) |
N=new indication
N=Hicw includion
Additional Comments: _Small organs includes: thyroid_parotid_submaxillary_gland_testes_and breast
Pediatric Intended uses include: Peripheral Vasa Pediatric Comments:
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED T
Concurrence of CDRH, office of Device Evaluation (ODE)
David Ch. Lyron
(Division Sign-Off) oductive Ab Division of and Radiological D Indication5fbf0(is): Number
Prescription Use (Per 21 CFR 801.109)
6
SonoScapeCompany,LTD.
510(K) Submission
SonsscapeCompany,LTD.
3.3 SONOSCAPE SSI-600/SS1800 Ultrasound Imaging System
Indications for Use Form
Diagnostic Ultrasound System Indications for Use Form
Device Name: SSI-600/SSI-800
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| A | B | M | PWD | CWD | Color | ||||||
| Doppler | Amplitude | ||||||||||
| Doppler | Color | ||||||||||
| Velocity | |||||||||||
| Imaging | Combined | ||||||||||
| (specify) | Other | ||||||||||
| (specify) | |||||||||||
| Ophthalmic | |||||||||||
| Fetal | N | N | N | ||||||||
| Abdominal | N | N | N | ||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative | |||||||||||
| Neurological | |||||||||||
| Pediatric | N | N | N | ||||||||
| Small Organ (specify) | N | ||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | N | N | N | ||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethrat | |||||||||||
| Intravascular | |||||||||||
| Perpheral Vascular | N | ||||||||||
| Laparoscopic | |||||||||||
| Musculo-skeletal | |||||||||||
| Conventional | |||||||||||
| Musculo-skeletal | |||||||||||
| superficial | |||||||||||
| Other (specify) |
N=new indication
Prescription Use (Per 21 CFR 801.109)
14 YOW Travents: _____________________________________________________________________________________________________________________________________________________________ Pediatric Comments: Pediatric Intended uses include: Peripheral Vasa
please do not write below this line - continue on another page if needed in
Concurrence of CDRH, office of Devige Evaluation (ODE)
David Ch. Lyram
(Division Division and Rad
Indications $1 (JKK) P